Chargé d'assurance qualité pharmaceutique

JR France; Bordeaux; Sur place; EUR 35 000 - 50 000; Plein temps

Résumé du poste

Une entreprise de conseil dédiée aux industries de la santé recherche un Chargé d'assurance qualité pharmaceutique à Bordeaux. Vous serez responsable de la validation des processus et de la révision des documents techniques, tout en collaborant avec les équipes pour assurer la conformité aux normes de qualité. Ce poste requiert un diplôme en pharmacie ou ingénierie et une expérience significative dans le domaine.

Qualifications

• Expérience significative en qualification/validation.
• Maîtrise de la validation des processus de fabrication, distribution, et emballage.

Responsabilités

• Réviser et approuver les stratégies de qualification/validation.
• Collaborer avec le contact Qualification/Validation pour superviser les phases de qualification.
• Contribuer aux investigations des non-conformités.

Connaissances

Validation de processus

Rédaction de protocoles de test

Formation

Diplôme en pharmacie ou ingénierie (Bac +5)

Description du poste

Chargé d'assurance qualité pharmaceutique, Bordeaux

Location: Bordeaux, France

Company: Caduceum, the Life Sciences solution of the ALTEN group, is a consulting company fully dedicated to the Healthcare industries. From product design to market launch, our teams support industrial players in the pharmaceutical, medical devices, biotechnological, and cosmetic sectors in all their innovation and transformation projects. Through our Technical Department, national coverage, and access to diverse projects within the healthcare industries, we ensure our team members develop their skills.

Role: As a Quality Assurance Officer specializing in qualification/validation, you will work at our client's site, adhering to current regulations and quality procedures. Your responsibilities will include:

1. Reviewing and/or approving qualification/validation strategies for production facilities, equipment, utilities, HVAC, cleanrooms, and processes.
2. Reviewing and/or approving technical documents such as master plans, protocols, test sheets, and reports.
3. Collaborating with the Qualification/Validation contact to oversee and coordinate different qualification phases (FAT/SAT/QI/QO/QP).
4. Participating in tests as necessary.
5. Contributing to and reviewing investigations of non-conformities and related actions.
6. Reviewing and/or approving analysis of results and conclusions regarding qualification/validation status.

Qualifications: A degree in pharmacy, engineering, or a related university program (Bac +5) with significant experience in qualification/validation. Skills acquired should include:

• Mastery of process validation (manufacturing, distribution, packaging at minimum).
• Experience in drafting test protocols.

For more information or to submit your application, please contact us at: contact.